BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MULTILOC HUMERAL NAIL

    MDR report key: 22335518 · Received June 26, 2025

    Report

    Report Number
    8030965-2025-06404
    Event Type
    Injury
    Date Received
    June 26, 2025
    Report Date
    June 26, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WILLEMS SA, GREEVEN APA. HUMERAL INTRAMEDULLARY NAIL BENDING FOLLOWING TRAUMA: A CASE REPORT. J TRAUMA INJ. 2023 MAR;36(1):65-69. DOI: 10.20408/JTI.2022.0002. EPUB 2022 JUN 17. PMID: 39381670; PMCID: PMC11309215. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS CASE REPORT IS TO PRESENT A RARE CASE OF HUMERAL NAIL BENDING AFTER SECONDARY TRAUMA IN A PATIENT WITH PREEXISTING NONUNION OF THE HUMERUS IS PRESENTED. A 71-YEAR-OLD, RIGHT-HAND-DOMINANT MALE PATIENT PRESENTED TO THE DEPARTMENT OF ACCIDENTS AND EMERGENCY AT THE HAGA TEACHING HOSPITAL FOLLOWING AN ICE-SKATING ACCIDENT. CLOSED REDUCTION AND INTERNAL FIXATION WERE PERFORMED USING A LONG MULTILOC NAIL (270 MM) WITH TWO SCREWS PROXIMALLY AS WELL AS DISTALLY. THE BUTTERFLY FRAGMENT WAS LOCATED SUFFICIENTLY AND THE IMPLANT POSITION WAS SECURED. POSTOPERATIVELY, NO COMPLICATIONS OCCURRED. DURING OUTPATIENT FOLLOW-UP, THE BONE SEEMED TO BE HEALING WELL 2 MONTHS AFTER SURGERY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES MULTILOC NAIL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: MULTILOC HUMERAL NAIL. (QTY 1) AN X-RAY EXAMINATION SHOWED DELAYED UNION OF THE FRACTURE (FIG. 2B). BECAUSE THE PATIENT HAD NO PAIN OR OTHER SYMPTOMS AT THIS STAGE, NO INTERVENTION WAS DONE AND A WAIT-AND-SEE POLICY WAS APPLIED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAILS: MULTILOC HUMERAL (QTY 1) AN X-RAY REVEALED A BENT HUMERAL NAIL WITH NONUNION OF THE HUMERUS. THE IMAGE SUGGESTED THAT THE NAIL WAS INTACT BUT HAD UNDERGONE PLASTIC DEFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537831 UNK - CONSTRUCTS: MULTILOC HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention